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Retrospective Chart Review of the 5 & 2 & 2 and 4 & 2 & 1 Plans

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ClinicalTrials.gov Identifier: NCT02150837
Recruitment Status : Completed
First Posted : May 30, 2014
Last Update Posted : May 30, 2014
Sponsor:
Information provided by (Responsible Party):
Medifast, Inc.

Brief Summary:

The purpose of this study is to retrospectively and systematically review records of overweight and obese Medifast Weight Control Center (MWCC) members who have been assigned to the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan for weight loss to gain a better understanding of the effectiveness of these programs. The study will describe demographics of this population, along with weight loss, anthropometrics, body composition and effects on available cardiovascular parameters. Adherence to the plans will also be examined.

The study hypothesis is that the 5 & 2 & 2 Meal Replacement Plan and the 4 & 2 & 1 Meal Replacement Plan are both effective programs for weight loss in overweight and obese adults.


Condition or disease Intervention/treatment
Obesity Other: 5 & 2 & 2 Plan Other: 4 & 2 & 1 Plan

Study Type : Observational
Actual Enrollment : 372 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Chart Review to Assess Weight Loss in Overweight and Obese Adults Using Either the 5 & 2 & 2 Meal Replacement Plan or the 4 & 2 & 1 Meal Replacement Plan at Medifast Weight Control Centers
Study Start Date : January 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
5 & 2 & 2 Plan
MWCC members who used the Medifast 5 & 2 & 2 Meal Replacement Plan for weight loss.
Other: 5 & 2 & 2 Plan
Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.

4 & 2 & 1 Plan
MWCC members who used the Medifast 4 & 2 & 1 Meal Replacement Plan for weight loss.
Other: 4 & 2 & 1 Plan
Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.




Primary Outcome Measures :
  1. Body weight [ Time Frame: 12 weeks ]
    The primary endpoint in this study is weight and the primary outcome is change from baseline body weight at 12 weeks for each plan (5 & 2 & 2 and 4 & 2 & 1 Plans); this change will be reported as both absolute and percent change. Change from baseline will also be examined at other predetermined time points (e.g., 1, 2, 4, 8, 16, 20 and 24 weeks, and final weight loss visit - the mean length of time from baseline to the final weight loss visit was 18.06 weeks for the 5 & 2 & 2 Plan and 17.35 weeks for the 4 & 2 & 1 Plan.).


Secondary Outcome Measures :
  1. Proportion of subjects who lose at least 5% of baseline body weight [ Time Frame: 12 weeks ]
    The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).

  2. Proportion of subjects who lose at least 10% of baseline body weight [ Time Frame: 12 weeks ]
    The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).

  3. Lean mass [ Time Frame: 12 weeks ]
    Lean mass expressed as an absolute and percent change from baseline and as percentage of total body mass.

  4. Fat mass [ Time Frame: 12 weeks ]
    Fat mass expressed as an absolute and percent change from baseline and as percentage of total body mass.

  5. Abdominal circumference [ Time Frame: 12 weeks ]
    Abdominal circumference expressed as an absolute and percent change from baseline.

  6. Waist circumference [ Time Frame: 12 weeks ]
    Waist circumference expressed as an absolute and percent change from baseline and as a waist to hip ratio.

  7. Hip circumference [ Time Frame: 12 weeks ]
    Hip circumference expressed as an absolute and percent change from baseline and as a waist to hip ratio.

  8. Blood pressure [ Time Frame: 12 weeks ]
    Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

  9. Pulse [ Time Frame: 12 weeks ]
    Pulse expressed as an absolute change from baseline.

  10. Blood pressure categorical [ Time Frame: 12 weeks ]
    Blood pressure will also be expressed as a categorical variable (normotensive, pre-hypertensive and hypertensive based on National Institute of Health Guidelines) and as a percent change in category from baseline to 12 weeks.

  11. Resting metabolic rate [ Time Frame: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan) ]
    Resting metabolic rate expressed as an absolute change from baseline to final weight loss visit (The average length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).

  12. Adherence [ Time Frame: 12 weeks ]
    Adherence will be assessed through attendance at weekly visits and documented use of meal replacements at each visit.

  13. Proportion of subjects who lose at least 5% of baseline body weight [ Time Frame: 1 weeks ]
    The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).

  14. Proportion of subjects who lose at least 5% of baseline body weight [ Time Frame: 2 weeks ]
    The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).

  15. Proportion of subjects who lose at least 5% of baseline body weight [ Time Frame: 4 weeks ]
    The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).

  16. Proportion of subjects who lose at least 5% of baseline body weight [ Time Frame: 8 weeks ]
    The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).

  17. Proportion of subjects who lose at least 5% of baseline body weight [ Time Frame: 16 weeks ]
    The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).

  18. Proportion of subjects who lose at least 5% of baseline body weight [ Time Frame: 20 weeks ]
    The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).

  19. Proportion of subjects who lose at least 5% of baseline body weight [ Time Frame: 24 weeks ]
    The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).

  20. Proportion of subjects who lose at least 5% of baseline body weight [ Time Frame: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan) ]
    The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans) at their final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).

  21. Proportion of subjects who lose at least 10% of baseline body weight [ Time Frame: 1 weeks ]
    The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).

  22. Proportion of subjects who lose at least 10% of baseline body weight [ Time Frame: 2 weeks ]
    The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).

  23. Proportion of subjects who lose at least 10% of baseline body weight [ Time Frame: 4 weeks ]
    The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).

  24. Proportion of subjects who lose at least 10% of baseline body weight [ Time Frame: 8 weeks ]
    The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).

  25. Proportion of subjects who lose at least 10% of baseline body weight [ Time Frame: 16 weeks ]
    The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).

  26. Proportion of subjects who lose at least 10% of baseline body weight [ Time Frame: 20 weeks ]
    The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).

  27. Proportion of subjects who lose at least 10% of baseline body weight [ Time Frame: 24 weeks ]
    The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).

  28. Proportion of subjects who lose at least 10% of baseline body weight [ Time Frame: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan) ]
    The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans) at their final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).

  29. Lean mass [ Time Frame: 4 weeks ]
    Lean mass expressed as an absolute and percent change from baseline and as percentage of total body mass.

  30. Lean mass [ Time Frame: 8 weeks ]
    Lean mass expressed as an absolute and percent change from baseline and as percentage of total body mass.

  31. Lean mass [ Time Frame: 16 weeks ]
    Lean mass expressed as an absolute and percent change from baseline and as percentage of total body mass.

  32. Lean mass [ Time Frame: 20 weeks ]
    Lean mass expressed as an absolute and percent change from baseline and as percentage of total body mass.

  33. Lean mass [ Time Frame: 24 weeks ]
    Lean mass expressed as an absolute and percent change from baseline and as percentage of total body mass.

  34. Fat mass [ Time Frame: 4 weeks ]
    Fat mass expressed as an absolute and percent change from baseline and as percentage of total body mass.

  35. Fat mass [ Time Frame: 8 weeks ]
    Fat mass expressed as an absolute and percent change from baseline and as percentage of total body mass.

  36. Fat mass [ Time Frame: 16 weeks ]
    Fat mass expressed as an absolute and percent change from baseline and as percentage of total body mass.

  37. Fat mass [ Time Frame: 20 weeks ]
    Fat mass expressed as an absolute and percent change from baseline and as percentage of total body mass.

  38. Fat mass [ Time Frame: 24 weeks ]
    Fat mass expressed as an absolute and percent change from baseline and as percentage of total body mass.

  39. Abdominal circumference [ Time Frame: 4 weeks ]
    Abdominal circumference expressed as an absolute and percent change from baseline.

  40. Abdominal circumference [ Time Frame: 8 weeks ]
    Abdominal circumference expressed as an absolute and percent change from baseline.

  41. Abdominal circumference [ Time Frame: 16 weeks ]
    Abdominal circumference expressed as an absolute and percent change from baseline.

  42. Abdominal circumference [ Time Frame: 20 weeks ]
    Abdominal circumference expressed as an absolute and percent change from baseline.

  43. Abdominal circumference [ Time Frame: 24 weeks ]
    Abdominal circumference expressed as an absolute and percent change from baseline.

  44. Waist circumference [ Time Frame: 4 weeks ]
    Waist circumference expressed as an absolute and percent change from baseline and as a waist to hip ratio.

  45. Waist circumference [ Time Frame: 8 weeks ]
    Waist circumference expressed as an absolute and percent change from baseline and as a waist to hip ratio.

  46. Waist circumference [ Time Frame: 16 weeks ]
    Waist circumference expressed as an absolute and percent change from baseline and as a waist to hip ratio.

  47. Waist circumference [ Time Frame: 20 weeks ]
    Waist circumference expressed as an absolute and percent change from baseline and as a waist to hip ratio.

  48. Waist circumference [ Time Frame: 24 weeks ]
    Waist circumference expressed as an absolute and percent change from baseline and as a waist to hip ratio.

  49. Hip circumference [ Time Frame: 4 weeks ]
    Hip circumference expressed as an absolute and percent change from baseline and as a waist to hip ratio.

  50. Hip circumference [ Time Frame: 8 weeks ]
    Hip circumference expressed as an absolute and percent change from baseline and as a waist to hip ratio.

  51. Hip circumference [ Time Frame: 16 weeks ]
    Hip circumference expressed as an absolute and percent change from baseline and as a waist to hip ratio.

  52. Hip circumference [ Time Frame: 20 weeks ]
    Hip circumference expressed as an absolute and percent change from baseline and as a waist to hip ratio.

  53. Hip circumference [ Time Frame: 24 weeks ]
    Hip circumference expressed as an absolute and percent change from baseline and as a waist to hip ratio.

  54. Blood pressure [ Time Frame: 1 weeks ]
    Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

  55. Blood pressure [ Time Frame: 2 weeks ]
    Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

  56. Blood pressure [ Time Frame: 4 weeks ]
    Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

  57. Blood pressure [ Time Frame: 8 weeks ]
    Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

  58. Blood pressure [ Time Frame: 16 weeks ]
    Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

  59. Blood pressure [ Time Frame: 20 weeks ]
    Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

  60. Blood pressure [ Time Frame: 24 weeks ]
    Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

  61. Blood pressure [ Time Frame: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan) ]
    Blood pressure (systolic and diastolic) expressed as an absolute change from baseline to final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).

  62. Pulse [ Time Frame: 1 weeks ]
    Pulse expressed as an absolute change from baseline.

  63. Pulse [ Time Frame: 2 weeks ]
    Pulse expressed as an absolute change from baseline.

  64. Pulse [ Time Frame: 4 weeks ]
    Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.

  65. Pulse [ Time Frame: 8 weeks ]
    Pulse expressed as an absolute change from baseline.

  66. Pulse [ Time Frame: 16 weeks ]
    Pulse expressed as an absolute change from baseline.

  67. Pulse [ Time Frame: 20 weeks ]
    Pulse expressed as an absolute change from baseline.

  68. Pulse [ Time Frame: 24 weeks ]
    Pulse expressed as an absolute change from baseline.

  69. Pulse [ Time Frame: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan) ]
    Pulse expressed as an absolute change from baseline to final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).

  70. Adherence [ Time Frame: 4 weeks ]
    Adherence will be assessed through attendance at weekly visits and documented use of meal replacements at each visit.

  71. Adherence [ Time Frame: 8 weeks ]
    Adherence will be assessed through attendance at weekly visits and documented use of meal replacements at each visit.

  72. Adherence [ Time Frame: 16 weeks ]
    Adherence will be assessed through attendance at weekly visits and documented use of meal replacements at each visit.

  73. Adherence [ Time Frame: 20 weeks ]
    Adherence will be assessed through attendance at weekly visits and documented use of meal replacements at each visit.

  74. Adherence [ Time Frame: 24 weeks ]
    Adherence will be assessed through attendance at weekly visits and documented use of meal replacements at each visit.

  75. Adherence [ Time Frame: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan) ]
    Adherence will be assessed through attendance at weekly visits and documented use of meal replacements at each visit from baseline (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).

  76. Body weight [ Time Frame: 1 week ]
    Change in body weight from baseline reported as both absolute and percent change.

  77. Body weight [ Time Frame: 2 weeks ]
    Change in body weight from baseline reported as both absolute and percent change.

  78. Body weight [ Time Frame: 4 weeks ]
    Change in body weight from baseline reported as both absolute and percent change.

  79. Body weight [ Time Frame: 8 weeks ]
    Change in body weight from baseline reported as both absolute and percent change.

  80. Body weight [ Time Frame: 16 weeks ]
    Change in body weight from baseline reported as both absolute and percent change.

  81. Body weight [ Time Frame: 20 weeks ]
    Change in body weight from baseline reported as both absolute and percent change.

  82. Body weight [ Time Frame: Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan) ]
    Change in body weight from baseline to final weight loss visit reported as both absolute and percent change. (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

This study is a systematic retrospective chart review of existing MWCC charts located in Maryland, Texas, Florida or Pennsylvania for MWCC members who used either the Medifast 5 & 2 & 2 Plan or the Medifast 4 & 2 & 1 Plan for weight loss.

Charts will be reviewed for members that started either the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan on or after January 1, 2012. This start date was chosen because it represents the date when Medifast began using the current versions of the 5 & 2 & 2 Plan and the 4 & 2 & 1 Plan. Only charts of those members who are no longer in the active weight loss phase of their program at the MWCC will be considered for the study.

Criteria

Inclusion Criteria:

  • Adult males and females, 18 years of age or older at the start of the weight loss program.
  • Subject has a BMI ≥ 25 kg/m2.
  • Subject started a weight management program at the MWCC location on or after January 1, 2012.
  • Subject followed the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan for at least the first two weeks of their weight loss phase while an active member of the MWCC.
  • Subject signed the Personal Health Information Consent Form.

Exclusion Criteria:

  • Subject was concurrently following another weight loss program other than the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan while on that respective plan.
  • Subject had documented use of prescription or over-the-counter weight loss pharmacotherapy (e.g., phentermine, Orlistat) concurrently with the 5 & 2 & 2 Plan or the 4 & 2 & 1 Plan.
  • Subject completed initial consultation but did not participate in any follow-up visits.
  • Subject is currently in the active weight loss phase of their program at the MWCC (Subjects in the transition or weight maintenance phases of their programs are eligible.)
  • Written request by subject to revoke consent to use health information is present in subject chart.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02150837


Locations
United States, Maryland
Medifast, Inc.
Owings Mills, Maryland, United States, 21117
Sponsors and Collaborators
Medifast, Inc.
Investigators
Principal Investigator: Linda M Aterburn, PhD Medifast, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medifast, Inc.
ClinicalTrials.gov Identifier: NCT02150837     History of Changes
Other Study ID Numbers: MED 017
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: May 30, 2014
Last Verified: May 2014

Keywords provided by Medifast, Inc.:
Obesity
Weight Loss
Meal replacements
Weight maintenance